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Penicillin for the Emergency Department Outpatient Treatment of CELLulitis (PEDOCELL)

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ClinicalTrials.gov Identifier: NCT02922686
Recruitment Status : Not yet recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Brief Summary:

The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half of the trial participants will receive flucloxacillin and placebo in combination, and the remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.

In a secondary objective the trial aims to measure adherence and persistence of trial patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin compared with combination therapy from the perspective of the health-care payer (direct costs) the patient and government. Finally the study will externally validate the Extremity Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in clinical trials.


Condition or disease Intervention/treatment Phase
Cellulitis Wound Infection Abscess Drug: Flucloxacillin Drug: Phenoxymethylpenicillin Drug: Placebo (for phenoxymethylpenicillin) Phase 4

Detailed Description:
There is obvious clinical equipoise between the use of oral flucloxacillin alone or combined with phenoxymethylpenicillin for the emergency department treatment of cellulitis, wound infections and abscesses as evidenced by current disparate prescribing practice and hospital guidelines. Feasibility studies for the planned trial have shown that 45-50% of emergency department patients with these infections in Ireland are discharged on oral antibiotics which is consistent with findings in other jurisdictions. Despite the significant healthcare and economic costs associated with cellulitis, there is a paucity of scientific evidence concerning the appropriate antibiotic treatment for these conditions. Additionally, "less severe" infections tend to be over-treated and severe infections under-treated, indicating unjustifiable levels of antibiotic misuse, insufficient knowledge of therapeutics and a lack of evidence to risk-stratify patients with cellulitis to different treatments.The planned trial is therefore likely to be definitive due to the current clinical equipoise between the use of both penicillins for the emergency department outpatient treatment of this group of infections

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oral Flucloxacillin Alone Versus Flucloxacillin and Phenoxymethylpenicillin for the Emergency Department Outpatient Treatment of Cellulitis: a Non-inferiority Randomised Controlled Trial.
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis

Arm Intervention/treatment
Active Comparator: flucloxacillin + phenoxymethylpenicillin
Flucloxacillin 500 mg four times daily + Phenoxymethylpenicillin 500 mg four times daily for 7 days.
Drug: Flucloxacillin
One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
Other Names:
  • Floxapen, 500 mg Capsules,
  • Marketing Authorisation Number PA1380/011/002

Drug: Phenoxymethylpenicillin
One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days
Other Name: Marketing Authorisation Number PL; 04520/0005

Placebo Comparator: flucloxacillin + placebo
Flucloxacillin 500 mg four times daily + Placebo four times daily for 7 days.
Drug: Flucloxacillin
One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
Other Names:
  • Floxapen, 500 mg Capsules,
  • Marketing Authorisation Number PA1380/011/002

Drug: Placebo (for phenoxymethylpenicillin)
Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles
Other Name: Over-encapsulated investigative medicinal product.




Primary Outcome Measures :
  1. Investigator-determined clinical response [ Time Frame: Test Of Cure visit (Day 14-21 post randomization) ]
    A trained member of the study team will determine clinical cure at the test of cure visit. This is a clinically-determined response to treatment based on the judgment of the trained member of the study team. Clinical cure will be defined as no treatment failure at any previous visit, and resolution or minimal presence of the erythema, swelling, tenderness, or induration from the baseline assessment, based on the study investigators clinical assessment


Secondary Outcome Measures :
  1. Early Clinical Response (ECR) [ Time Frame: Day 2-3 post randomization ]
    Early clinical response is defined as greater than or equal to a 20% reduction in the lesion surface area from that which was measured at enrolment.

  2. Clinical Treatment Failure [ Time Frame: Up to 21 days post randomization ]
    Any patient outcome designated as a clinical treatment failure at any time before and including the test of cure visit, will be categorized as a treatment failure. This commences with the early clinical response visit and includes serial changes in the surface area of the cellulitis lesion (erythema, oedema, tenderness and induration), clinical assessment of progress and health related quality of life measurements.

  3. Adherence to Medication [ Time Frame: End of Treatment (EOT) visit Day 8-10 post randomization ]
    Medication adherence will be measured by counting the number of unused study medication at the end of treatment visit

  4. Adherence to medication using an electronic medication event monitoring system (MEMS®) [ Time Frame: Day 2-3 and day 8-10 post randomization and initiation of therapy ]
    A specific sub-study will be performed measuring adherence and persistence to antibiotic treatment using a MEMS® cap. The cap will be fitted to the dispensed medication bottle. MEMS® caps will be returned with the clinical trials supplies on the follow up visits.medication at the end of treatment visit

  5. Measurement of Health Related Quality of Life [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]
    The EuroQol (EQ-5D-5L) will be used to obtain patient reports of health related quality of life and used in the estimation of quality adjusted life years.

  6. Validation of the Extremity Soft Tissue Infections (ESTI)- score [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]
    The ESTI will be used to obtain patient reports of health related quality of life and will be mapped on to EQ-5D-5L levels, to assess the accuracy of ESTI for use in cost-effectiveness studies

  7. Cost-effectiveness analysis [ Time Frame: Day 14 - 21 post randomization ]
    Analysis will consist of a within-trial evaluation of the cost QALY for oral flucloxacillin compared with oral flucloxacillin and phenoxymethylpenicillin over a one month time horizon from the perspective of the healthcare payer, the patient and the government. The CE analysis will use resource use data, where costs will be assigned to derive cost and will also use the QALY derived from the EQ5D-5L, to give overall cost per QALY.

  8. Measurement of Health Resource Use [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]
    A health economics resource utilization tool is being constructed to collect data on resource use, e.g. direct costs- hospital visits, primary care visits, and indirect costs such as transport and lost work productivity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically diagnosed cellulitis, wound infections or abscess (ABSSSI) affecting any body part, excluding the perineum, and having any two of the following signs:

    • Erythema
    • Warmth
    • Tenderness / Pain of affected area
    • Oedema / Induration
    • Regional lymphadenopathy
  • Cellulitis, wound infection and abscess deemed treatable with oral outpatient antibiotics in which either combination of antibiotic is likely to produce a clinical response (Eron Class 1-2)
  • Written informed consent obtained.
  • 16 years of age or older.
  • Fluency in written and spoken English.
  • Willing to return for study follow-up or to have the research nurse visit their home.
  • Willing to receive a telephone call from a study investigator.

Exclusion Criteria:

  • Penicillin allergy (self-reported or confirmed).
  • Any cellulitis, wound infection and abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
  • Any cellulitis, wound infection and abscess that is more severe than Eron Class 2 (Appendix 2)
  • Any cellulitis, wound infection and abscess of the perineal region.
  • Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection or abscess
  • Any medical condition, based on clinical judgment, that may interfere with interpretation of the primary outcome measures (e.g. chronic skin condition at the lesion site)
  • Immunodeficiency from primary or secondary causes (e.g. corticosteroids, chemotherapeutic agents).
  • Previous history of renal dysfunction or known chronic kidney disease under care of a nephrologist. - Previous history of liver dysfunction defined as chronically deranged liver function tests elicited from medical notes or history.
  • Suspected or confirmed septic arthritis.
  • Suspected or confirmed osteomyelitis.
  • Infection involving prosthetic material.
  • Pregnant or lactating women.
  • Patients with a previous history of flucloxacillin- associated jaundice/hepatic dysfunction
  • Patients with a previous history of MRSA colonization/infection.
  • Patients with lactose intolerance diagnosed by a medical professional

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922686


Contacts
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Contact: Abel Wakai, MD FRCEM 003531 8093000 awakai@rcsi.ie
Contact: Michael Quirke, MB FRCEM 00353 1 8093000 michaelquirke@rcsi.ie

Locations
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Ireland
Department of Emergency Medicine, Connolly Hospital, Not yet recruiting
Blanchardstown, Dublin, Ireland, Dublin 15
Contact: Joseph McKeever       joseph.mckeever@hse.ie   
Department of Emergency Medicine, Mercy University Cork Not yet recruiting
Cork, Greenville Place, Ireland, Cork
Contact: Chris Luke         
Department of Emergency Medicine, Cork University Hospital Not yet recruiting
Cork, Wilton, Ireland, Cork
Contact: Conor Deasy       conor.deasy@hse.ie   
Department of Emergency Medicine, Mater Misericordiae University Hospital Not yet recruiting
Dublin, Ireland, Dublin 7
Contact: Adrian Moughty       amoughty@mater.ie   
Contact: Michael Quirke         
Beaumont Hospital, Not yet recruiting
Dublin, Ireland, Dublin 9
Contact: Abel Wakai, MD FRCEM       awakai@rcsi.ie   
Contact: Michael Quirke       michaelquirke@rcsi.ie   
Principal Investigator: Abel Wakai, MD FRCEM         
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Research Board, Ireland
Investigators
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Principal Investigator: Adrian Moughty Mater Misericordiae University Hospital
Principal Investigator: Joseph McKeever Connolly Hospital Blanchardstown
Principal Investigator: Conor Deasy Department of Emergency Medicine, Cork University Hopsital, Cork
Principal Investigator: Chris Luke Department of Emergency Medicine, Mercy University, Cork
Principal Investigator: Abel Wakai, MD FRCEM Department of Emergency Medicine, Beaumont Hospital, Dublin

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT02922686     History of Changes
Other Study ID Numbers: EudraCT Number: 2016-001528-69
HRB HRA Project ID ( Other Grant/Funding Number: HRA-DI-2015-1297 )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Wound Infection
Cellulitis
Emergencies
Disease Attributes
Pathologic Processes
Infection
Suppuration
Inflammation
Skin Diseases, Infectious
Connective Tissue Diseases
Floxacillin
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents